Formulation and Drug Delivery

Celgene Partners with Jounce Therapeutics for Immunotherapy Development

July 19, 2016

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

Ionis Pharmaceuticals Licenses Oral RNA-based Therapeutic to Janssen

July 19, 2016

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

SmithKline Beecham Gets Warned for Contamination

July 19, 2016

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

Are Oral Peptide Drugs on the Horizon?

July 14, 2016

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

Sandoz's Biosimilar to Enbrel Gets FDA Support Ahead of Panel

July 11, 2016

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.

Federal Court Weighs in on Biosimilar Patent Dance

July 08, 2016

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

BioOutsource Launches IgG Glycosylation Tool

July 07, 2016

The assay will provide information on biosimilar comparability.

Novo Nordisk Expands Insulin Manufacturing Facility in Denmark

July 06, 2016

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Teligent Breaks Ground on Manufacturing and R&D Expansion

July 06, 2016

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Planning a Biologics Facility Start Up

July 02, 2016

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.